Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery

NCT ID: NCT06050044

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-07-01

Brief Summary

The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.

Detailed Description

Spinal anesthesia is one of the most commonly used nerve block procedures for surgical operations involving the lower abdomen, the perineum, and the lower limbs, owing to its quick effect and cost-effectiveness. Spinal anesthesia is advantageous in that it uses a small dose of anesthesia, is simple to perform, and offers a rapid onset of action, reliable surgical analgesia, and good muscle relaxation.

The Baricity of a solution is defined as the ratio of the density of the solution to that of the cerebrospinal fluid (CSF). The most common anesthetic used for SA in obstetric and non-obstetric surgery is bupivacaine, which can be formulated as an isobaric or hyperbaric solution. Baricity differences between spinal anesthetic solutions are thought to affect hemodynamic parameters and distribution within the subarachnoid space, which may, in turn, affect the onset, extent, and duration of sensory block as well as side effects.

Spinal anesthesia has been linked to different adverse effects, out of which hypotension is most common complication. The incidence of hypotension is 25-75% in general population. Factors that increase the risk of hypotension include patient factors (advanced age, pregnancy, obesity, diabetes mellitus, hypertension, and anemia) and technical factors such as a block level at or above T5, use of opioids during premedication, and high local anesthetic dosages.

Conditions

Spinal Anesthesia; Hyperbaric Bupivacaine; Isobaric Bupivacaine; Lower Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (hyperbaric bupivacaine)

Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution.

Group Type: EXPERIMENTAL

Group A (hyperbaric bupivacaine)

Intervention Type: DRUG

Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution.

Group Type: EXPERIMENTAL

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Intervention Type: DRUG

Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution

Interventions

Group A (hyperbaric bupivacaine)

Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution

Intervention Type: DRUG

Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)

Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18-65 years old.
• Both sexes.
• American Society of Anaesthesia (ASA) I to II.
• Undergoing lower abdominal or urological surgery under spinal anesthesia

Exclusion Criteria

• Allergy to amide.
• Patients with a significant history of substance abuse.
• Patients with diabetes mellitus, neurological or cardiovascular diseases.
• Patients with neuromuscular diseases.
• Pregnant patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Adel Ali Hassan

Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Helwan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helwan University

Helwan, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

48-2022

Identifier Type: -

Identifier Source: org_study_id